Kornimate/medical-research-clean huggingface dataset:
a study of jnj-78278343, a t-cell-redirecting agent targeting human kallikrein 2 (klk2), for advanced prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to determine the recommended phase 2 dose(s) (rp2ds) of jnj-78278343 in part 1 (dose escalation) and the safety at the rp2ds in part 2 (dose expansion).


Eligibility criteria:
inclusion criteria: * confirmed adenocarcinoma of the prostate which has spread to other body parts * part 1: prior treatment with at least 1 prior novel androgen receptor (ar)-targeted therapy or chemotherapy * measurable or evaluable disease * concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug * eastern cooperative oncology group (ecog) performance status of 0 or 1 * prior surgical removal of testicles; or, for participants who have not undergone surgical removal of testicles, must be receiving ongoing androgen deprivation therapy (adt) with a gonadotropin releasing hormone analog exclusion criteria: disease conditions * active central nervous system (cns) involvement * toxicity related to prior anticancer therapy has not adequately recovered prior/concomitant therapy * prior treatment with human kallikrein (klk) 2-targeted therapy * received, or are receiving, medications that suppress the immune system within 3 days prior to the first dose of study drug * received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug prior/concurrent medical conditions * diagnosis of cancer other than prostate cancer within 2 years prior to the first dose of study drug * solid organ or bone marrow transplantation * major clotting diseases within one month prior to the first dose of study drug * active autoimmune disease within 12 months prior to the first dose of study drug * active infection * major diseases of heart and blood vessels within 6 months prior to the first dose of study drug * clinically significant lung diseases * active or chronic hepatitis b or hepatitis c infection * known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load) * any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment

Keywords: metastatic castration-resistant prostate cancer (mcrpc) advanced prostate cancer
digital psychological self-care for sleep problems

Conditions: Chronic Insomnia

Summary: in this non-randomized treatment feasibility pilot we want to explore if a simplified version of cbt-i as a non-therapist-guided digital tool can work; if the digital tool is perceived as user friendly and if participants' insomnia severity is improved following four weeks of treatment.


Eligibility criteria:
inclusion criteria: * insomnia complaints of at least medium severity (15 or above on the isi) * insomnia disorder according to dsm-5 * adequate language skills (swedish) * no foreseeable practical hinders to participate * can wear actigraph 24/7 * daily access to the internet, via computer, smart phone or tablet exclusion criteria: * sleep disorders requiring other treatment (e.g. sleep apnea) * somatic or psychiatric disorders that require other treatment (e.g. suicide risk, severe depression) or that decrease level of functioning enough to prevent working independently. * use of alcohol or drugs in a way that will affect sleep negatively, use of medications with a negative impact on sleep. (stable use of anti depressants and stable use or tapering of hypnotics are allowed) * night work or shift work involving night work * ongoing or previous psychological treatment including sleep restricion and stimulus control

Keywords: digital tool self-guided
effect of high-intensity low-volume training on insulin sensitivity in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: high intensity interval training is applied for several diseases. hypothesis: high intensity interval training improves insulin sensitivity in patients with type 2 diabetes.

type 2 diabetes mellitus is a multifactorial metabolic disease that is characterized by reduced insulin sensitivity and insulin production leading to impaired glucose tolerance. overweight and low physical activity are the main risk factors for the development of type 2 diabetes. increased physical activity has shown to improve insulin sensitivity, hence, exercise plays a significant role in the prevention and therapy of type 2 diabetes. this study aims at investigating the acute and chronic effects of high-intensity low-volume training, that consists of brief bursts of very vigorous exercise separated by recovery periods, on metabolic function in patients with type 2 diabetes, people at high risk for the disease and healthy, lean individuals. study participants take part in 30 min training session three times a week for a period of 12 weeks. participants are studied on four occasions, prior to the intervention, after an acute bout of exercise as well as after 6 and 12 weeks of training in order to assess physical fitness, body composition, insulin sensitivity, energy metabolism in muscle, adipose tissue inflammation and neurological function. it is hypothesized that this type of exercise leads to significant improvements in insulin action and oxidative phosphorylation in muscle

Eligibility criteria:
inclusion criteria: * men and women * age: 30 - 65 years * typ-2-diabetes (bmi \> 25 kg/m²) * increased risk for diabetes (bmi \>25 kg/m²) exclusion criteria: * acute infection within the last 2 weeks prior to the intervention * autoimmune diseases and immune suppressive diseases (leukocytes \< 5000/μl) * intake of immunomodulating drugs (glucocorticoids, antihistamine, ass) * pregnancy, breastfeeding, menstruation * kidney insufficiency (creatinine \> 1,5 mg/dl) * cardiovascular diseases * anemia (hb \< 12g/l), disorders of wound healing or blood clotting * participation in another study within the last 2 months before the investigation * metallic or magnetic items on or in the body * claustrophobia * thyroid dysfunction * intake of glitazones or insulin therapy * smoking (non-smoking since \> 1 year), alcohol consumption (men \> 30 g/d, women \> 20g/d) or illegal drugs * psychiatric disorders * risk for/or manifest aids (hiv) or hepatitis b or c * night shift working * hypersensitivity to local anesthetics * cancer disease * lung diseases * systematic endurance training (\>1x per week \> 60min.) * maximal oxygen consumption (vo2 max) \<20ml/min/kg * orthopedic disorders * musculoskeletal diseases

Keywords: type 2 diabetes exercise intervention high intensity interval training
evaluation the effect of coenzyme q10 on tissue healing process in patients undergoing wisdom tooth extraction

Conditions: Molar, Third; Temporomandibular Joint Disorders; Dry Socket; Coenzyme Q10

Summary: the goal of this clinical trial is to asses the effect of coenzyme q10 administration in patients from any gender group who are older than 18 years old undergoing wisdom tooth extraction. the main questions it aims to answer are: does coenzyme q10 help with better tissue healing? does coenzyme q10 administration lower the prevalence of dry socket after surgery? does coenzyme q10 prevent tmd (temporomandibular disorders) while recovering from surgery? how does coenzyme q10 administration effect the answers to sf-36 health survey in patients? researchers will compare coenzyme q10 to a placebo (a look-alike substance that contains no drug) to see if it has any effect on mentioned parameters. participants will: * take coenzyme q10 (100mg) daily for 30 days after surgery. * will be examined and evaluated 1, 7, 14 and 30 days after completion of surgery.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old that require mandibular or maxillary molar, third tooth extraction as oral and maxillofacial surgeon's clinical diagnosis. exclusion criteria: * the patient's departure from sanandaj * the patient's disagreement with the study protocol * the patient's demise * the patient's hospitalization for unrelated illnesses * the patient's discontent with the care they received * the patient's failure to show up for follow-up appointments * the patient's sensitivity to coenzyme q10

Keywords: coenzyme q10 dry socket temporomandibular joint disorders molar, third sf-36 health survey tissue healing tooth extraction ghq-12
pharmacokinetics study of mci-186 in subjects with mild or moderate hepatic impairment

Conditions: Hepatic Impairment; Healthy

Summary: to assess the pharmacokinetics of mci-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate hepatic impairment compared to subjects with normal hepatic function


Eligibility criteria:
inclusion criteria: all subjects * able to provide written informed consent to participate in this study after reading the icf * subjects is able to understand and willing to cooperate and comply with the protocol restrictions and requirements. * a body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2 hepatic impaired subjects (in addition) * a child-pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment * chronic and stable hepatic impairment healthy subjects (in addition) * subject with normal hepatic function * good health and free from clinically significant illness or disease exclusion criteria: all subjects * presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance * subjects were previously administered mci-186. * positive urine drug screen (if not due to concomitant medication) or alcohol test * history of drug abuse * presence of alcohol abuse * presence of active infection requiring antibiotics * positive test for human immunodeficiency virus (hiv) antigen/antibody * uncontrolled, or untreated hypertension defined as systolic blood pressure (sbp)\>160 mmhg and/or diastolic blood pressure (dbp)\>100 mmhg * egfr \<60 ml/min/1.73m2 hepatic impairment subject (in addition) * subjects with severe ascites healthy subject (in addition) * history or presence of any parenchymal hepatic disease * positive test for hepatitis b surface antigen (hbsag) and hepatitis c virus antibody (hcvab)
safety and efficacy of low intensity shockwave therapy in treating diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: low intensity shockwaves for treating diabetic foot ulcers (dfus) have been in evaluation for the past 5 years. many researchers showed the effectiveness of low intensity shockwaves of in accelerating the healing rate of non-ischemic chronic dfus. wang et al. showed, the use of low intensity shockwaves on dfus, significantly improved topical blood flow perfusion rate, increased cell proliferation and cell activity and decreased cell apoptosis. the present study deals with the effect of low intensity shockwaves on dfus. shockwave treatment will be done together with the standard conventional treatment for dfus, compared to a control group who will receive the same conventional standard of care.


Eligibility criteria:
* inclusion criteria: 1. chronic non-healing diabetic foot ulcers for more than 2 months. 2. age 18-80 years 3. ankle brachial index (abi) ≥0.6 4. diabetic foot ulcer with the long diameter of ≤7cm and a short diameter of ≥1cm 5. the target ulcer is up to wagner's grade 3 6. albumin level ≥25g/l 7. hemoglobin level ≥90g/l 8. estimated glomerular filtration rate (egfr) ≥30ml/min/1.73m2 9. the patient agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the ulcer (dressings, orthotics etc.) and all follow-up visit requirements * exclusion criteria: 1. pregnancy or lactation 2. abi \<0.6 3. the long diameter of the target ulcer is \>7cm and the short diameter is \<1cm 4. the target ulcer is of wagner's grade 4 or above 5. severe hypoalbuminemia \<25g/l 6. severe anemia, hemoglobin level \<90g/l 7. egfr \<30ml/min/1.73m2 8. patients suffering from acute charcot foot 9. severe edema of the treated limb 10. patient with present malignancy or past malignancy in the treated area 11. systemic chemotherapy/ radiation treatment within the last 6 months 12. deep vein thrombosis within the last 6 months 13. any other experimental treatment or participation in other studies -
pregnant obese women and fetal ultrasound quality.

Conditions: Obese Women; Pregnant Women

Summary: ultrasound (us) image construction uses equations that contain the value of the propagation velocity of sound waves; this velocity is assumed conventionally to be constant and equal to 1540 m/s in the human body. since 1977, all manufacturers of us scanners have used this value, which was first established in 1950. in fatty tissue, however, the actual propagation velocity is only in the order of 1450 m/s. us velocity in fat tissue is slower than in other soft tissues (ie:1450 m/s vs 1540 m/s) therefore the intrinsic image quality in terms of sharpness and precision is improved when considering this parameter for image construction the main objective of this study is to evaluate the impact of ultrasound propagation velocity setting on completeness of ultrasound exams and images quality during the second and third trimester fetal ultrasound examination in obese patients.

obese pregnant women will be included before the second trimester fetal ultrasound examination. women will be allocated to one intervention group or to the control group. in the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam. in the control group, exam will be performed using the conventional ultrasound velocity. an exam will be considered to be complete if all the images recommended by national guideline are acquired. if ultrasound images are missing, other ultrasound exams may be performed until completeness is reached. the protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline. all scans will be evaluated by two independent experts who do not have performed any of the exams. they will evaluate the completeness of each exam. each scan will be quoted using the quality score proposed by salomon et al.

Eligibility criteria:
inclusion criteria: * body mass index\>30 * between 20 and 25 weeks of gestation exclusion criteria: * multiple pregnancy * uterine scare

Keywords: fetal ultrasound ultrasound propagation velocity image quality obese women
school-based preventive asthma care technology: a trial using a novel technology to improve adherence

Conditions: Asthma

Summary: the goal of this new translational project is to test the feasibility and effectiveness of implementing school-based directly observed therapy of preventive asthma medications in a real-world setting, using state-of-the-art web-based technology for systematic screening, electronic report generation, and communication between nurses, caregivers, and primary care providers. with the use of a novel method to improve adherence and subsequently reduce morbidity, the investigators hypothesize that this novel adaptation of school-based asthma care will; 1) be feasible and acceptable among this population and among school and community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). the investigators anticipate that enhancing preventive healthcare for young urban children with asthma through partnerships with the schools using a novel technology will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.


Eligibility criteria:
inclusion criteria (all 4 criteria must be met): 1. physician-diagnosed asthma (based on parent report). 2. persistent asthma (criteria based on nhlbi guidelines). any 1 of the following: 1. an average of \>2 days per week with asthma symptoms 2. \>2 days per week with rescue medication use 3. \>2 days per month with nighttime symptoms 4. ≥2 episodes of asthma during the past year that have required systemic corticosteroids 3. age ≥3 and ≤10 years. 4. attending school in participating rochester city school district preschools or elementary schools. exclusion criteria: 1. inability to speak and understand english. (\*parents unable to read will be eligible, and all instruments will be given verbally.) 2. no access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number). 3. family planning to leave the school district within fewer than 6 months. 4. the child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. 5. children in foster care or other situations in which consent cannot be obtained from a guardian.

Keywords: asthma
a study on the effects of exercise therapy on signs of prostate cancer

Conditions: Prostate Cancer; Prostate Adenocarcinoma; Localized Prostate Carcinoma

Summary: the purpose of this study is to find out the effects of exercise therapy on indicators of prostate cancer in people with low-risk prostate cancer who are on active surveillance. the exercise therapy in this study will be regular home-based walking sessions on a treadmill, and that therapy will be assigned by an exercise physiologist (a medical professional who studies how exercise affects the human body). some participants in this study will have the assigned exercise therapy, and some participants will participate in their usual exercise routines. researchers will compare how the assigned exercise therapy and the usual exercise routines affect indicators of prostate cancer in participants. this study will not provide treatment for prostate cancer.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * men with histologically confirmed localized prostate cancer undergoing active surveillance. * inactive, defined as not meeting the national exercise guidelines for cancer patients (\<150 minutes/week of moderate or vigorous exercise)43 as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry (general physical activity screening assessment via smart watch). * screening clearance by an msk exercise physiologist (i.e., review of ecg) * bmi \<40 kg/m\^2 * cleared for exercise participation as per pre-screening clearance via the physical activity readiness questionnaire (par-q+) (appendix b) exclusion criteria: * enrollment in any other program that may alter the impact of exercise on tumor outcomes (e.g., weight loss program) * any neoadjuvant anticancer treatment of any kind for prostate cancer in the last 5 years * any history of systemic anticancer therapy in the last 15 years * distant metastatic malignancy of any kind * any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Keywords: prostate cancer prostate adenocarcinoma localized prostate carcinoma exercise therapy memorial sloan kettering cancer center 22-419
effect of cer-001 on plaque volume in homozygous familial hypercholesterolemia (hofh) subjects

Conditions: Homozygous Familial Hypercholesterolemia

Summary: the available medications used to treat hofh are targeted at reducing circulating levels of total and ldl-cholesterol. these measures can retard the progression of cardiovascular disease, however, they are unlikely to regress existing disease due to years of cholesterol accumulation in the vessel walls and therefore cannot adequately reduce the existing risk for an ischemic event. hdl has multiple actions that could lead to plaque stabilization and regression, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. this study will assess the effects of cer-001, a recombinant human apo-a-1 based hdl mimetic, on indices of atherosclerotic plaque progression and regression as assessed by 3tesla mri measurements in patients with hofh.


Eligibility criteria:
inclusion criteria: * male or female subject 12 years or older * subject presents with homozygous fh exclusion criteria: * weight \>100 kg * subjects with significant health problems in the recent past including blood disorders, cancer, or digestive problems * female subjects of child-bearing potential * known major hematologic, renal , hepatic, metabolic, gastrointestinal or endocrine dysfunction * contraindication to mri scanning that would preclude the use of contrast-enhanced 3tmri

Keywords: homozygous familial hypercholesterolemia familial hypercholesterolemia hdl mimetic apoa-1
major depressive disorder (mdd) with mixed features - flexible dose

Conditions: Major Depressive Disorder With Mixed Features

Summary: lurasidone hcl is a compound that is a candidate for the treatment of major depressive with mixed features.this clinical study is designed to test how well lurasidone works to treat major depressive disorder with mixed features.


Eligibility criteria:
inclusion criteria: * subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator. * subject is 18 to 75 years of age, inclusive. * subject has mdd (diagnosed by dsm-iv-tr, and confirmed by the structured - clinical interview for dsm-iv disorders - clinical trial version \[scid-ct\]). * subject is currently experiencing a major depressive episode (diagnosed by dsm iv tr; at least 2 weeks in duration) and two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the scid-ct modified for study d1050304): * elevated, expansive mood * inflated self-esteem or grandiosity * more talkative than usual or pressure to keep talking * flight of ideas or subjective experience that thoughts are racing * increase in energy or goal-directed activity (either socially, at work or school, or sexually) * increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments) * decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia) exclusion criteria: * subject has axis i or axis ii diagnosis other than mdd that has been the primary focus of treatment within the 3 months prior to screening. * subject answers "yes" to "suicidal ideation" item 4 or 5 on the c-ssrs (at time of evaluation) at screening or baseline visit. * subject has attempted suicide within the past 3 months. * subject has a lifetime history of any bipolar i manic or mixed manic episode. * subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the investigator.

Keywords: depression lurasidone latuda